| Eligibility |
Inclusion Criteria:
To enter the study, a subject must meet the following criteria:
1. Subject is male, 18-55 years old.
2. Subject has provided written informed consent.
3. Subject has a clinical diagnosis of mild to moderate androgenetic alopecia (AGA) in
temple and vertex region with a score of IIIv, IV, or V on the Modified
Norwood-Hamilton Scale.
4. Subject, in the investigator's opinion, is in good general health and free of any
disease state or physical condition that might impair evaluation of AGA or exposes the
subject to an unacceptable risk by study participation.
5. Subject has normal renal, thyroid, and hepatic function as determined by the Visit
1/Screening laboratory results in the opinion of the investigator.
6. Subject is a non-smoker, defined as not having smoked or used any form of tobacco or
non-tobacco products containing nicotine in more than 4 months before Visit
2/Baseline.
7. Subject is willing to maintain the same hair style, hair length, and hair color
throughout the study.
8. Subject agrees to continue his other general hair care products and regimen for at
least 2 weeks prior to Visit 2/Baseline, and through the entire study.
9. Subject is willing and able to apply the investigational product (IP) as directed,
comply with study instructions, and commit to all follow-up visits for the duration of
the study.
10. Subjects who are sexually active with a female partner and are not surgically sterile
( vasectomy performed at least 6 months prior to treatment) must agree to refrain from
sperm donation for at least 90 days after administration of their last dose of IP and
inform their non-pregnant female sexual partner to use a highly effective form of
birth control1 as described in the informed consent form. Note: Female partner must be
confirmed according to subject to be non-pregnant at Visit 1/Screening and Visit
2/Baseline or at the visit when a subject identifies a new sexual partner.
Exclusion Criteria:
A subject is ineligible to enter the study if he meets 1 or more of the following criteria:
1. Subject has any dermatological disorders of the scalp on the regions that are bald and
thinning with the possibility of interfering with the application of the IP or
examination method, such as fungal or bacterial infections, seborrheic dermatitis,
psoriasis, eczema, folliculitis, scars, or scalp atrophy.
2. Subject has history or active hair loss due to diffuse telogen effluvium, alopecia
areata, scarring alopecia, trichotillomania, or conditions/diseases other than AGA.
3. Subject has any skin pathology or condition (e.g., uncontrolled thyroid disease,
certain genetic disorders that involve hair growth or patterns) that, in the
investigator's opinion, could interfere with the evaluation of the IP or requires use
of interfering topical, systemic, or surgical therapy.
4. Subject has any visible inflammatory skin disease, injury, or condition of their scalp
that could compromise subject safety and/or interfere with the evaluation of local or
systemic assessments performed during the study.
5. Subject has history (within 6 months of Visit 1/Screening) of severe dietary or weight
changes or history of eating disorder(s), which has resulted in hair loss, in the
opinion of the investigator.
6. Subject has a history of scalp reduction or notable trauma with related scarring, hair
transplants, and/or hair weaves.
7. Subject has a known or suspected malignancy excluding cutaneous basal cell carcinoma
or cutaneous squamous cell carcinoma not located within the treatment area.
8. Subject has a positive blood screen for human immunodeficiency virus (HIV), hepatitis
B surface antigen (HBsAg), or hepatitis C antibody.
9. Subject has any condition, which, in the investigator's opinion, would make it unsafe
for the subject to participate in this study, including clinically significant
abnormal laboratory, or 12-lead electrocardiogram (ECG) findings during the screening
period or Visit 2/Baseline prior to dosing of the IP.
10. Subject has used any topical scalp treatments for hair growth including minoxidil,
hormone therapy, anti-androgen, or other agents known to affect hair growth within 12
weeks of Visit 2/Baseline.
11. Subject has used any topical scalp over-the-counter (OTC) or cosmetic treatments known
or reasonably believed to affect hair growth (e.g., brands such as Aminexil, Maxilene,
Nioxin, Foltene) or hair growth products with saw palmetto, copper, etc. within 4
weeks of Visit 2/Baseline.
12. Subject has used any topical scalp treatments that may have ancillary effects on hair
growth including, but not limited to, corticosteroids, pimecrolimus, tacrolimus, and
retinoids within 4 weeks of Visit 2/Baseline.
13. Subject has had any scalp procedures, including surgical, laser, light or energy
treatments, micro-needling, etc. within 6 months of Visit 2/Baseline.
14. Subject has had platelet rich plasma (PRP) procedures on the scalp at any time.
15. Subject has used systemic beta blockers, cimetidine, ketoconazole, diazoxide, or
corticosteroids (including intramuscular and intralesional injections) within 12 weeks
of Visit 2/Baseline. Inhaled, intranasal, or ocular corticosteroids are allowed if use
is stable. Stable is defined as doses and frequency unchanged for at least 4 weeks
prior to Visit 2/Baseline.
16. Subject has used systemic retinoids, isotretinoin, vitamin A intake above 10,000 IU
per day, or cyclosporine therapy within 6 months of Visit 2/Baseline.
17. Subject has used finasteride (e.g., Propecia®), dutasteride, minoxidil (oral), or
similar products within 6 months of Visit 2/Baseline.
18. Subject has used chemotherapy or cytotoxic agents within 12 months of Visit
2/Baseline.
19. Subject has had radiation of the scalp at any point.
20. Subject has used any other systemic therapy, which in the opinion of the investigator,
may materially affect the subject's hair growth, including, but not limited to,
vitamin or homeopathy supplement hair growth or hair health products or other steroid
hormones (in any form), including anabolic steroids.
21. Subject is currently enrolled in an investigational drug, biologic, or device study.
22. Subject has used an investigational drug, investigational biologic, or investigational
device treatment within 30 days or 5 half-lives, whichever is longer, prior to Visit
2/Baseline.
23. Subject has previously been treated with the IP.
24. Subject has a history of prescription drug abuse, or illicit drug use within 6 months
prior to Visit 1/Screening.
25. Subject has a history of alcohol abuse according to medical history within 6 months
prior to Visit 1/Screening.
26. Subject has a positive screen for alcohol or drugs of abuse at Visit 1/Screening or
Visit 2/Baseline.
27. Subject has signs or symptoms consistent with Coronavirus Disease-19 (COVID-19) at
Visit 1/Screening or Visit 2/Baseline or has been diagnosed with COVID-19 within 4
weeks of Visit 1/Screening.
28. Subject has a history of sensitivity to any of the ingredients in the IP or tattoo
ink.
29. Subject is known to be noncompliant or is unlikely to comply with the requirements of
t the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in
the opinion of the investigator.
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